Peter Rose, Managing Director—Europe, Maetrics09.06.19
The days remaining to attain EU Medical Device Regulation (MDR) compliance are numbered, while the notified bodies central to manufacturers achieving said compliance are few and far between. With a significant shortage of notified bodies in the European regulatory arena, the risk is real for manufacturers who wait too long to get their compliance matters in order. Any manufacturer unable to receive CE certification by the upcoming deadline on May 26, 2020, or by the end of any extended transition period according to current Medical Device Directive (MDD) certificate expiry date, will have to deal with the regrettable consequence of having their products removed from the EU market, and any associated cash-flow repercussions and reputational damages to their business.
Particularly vulnerable to being left behind are Class I manufacturers who cannot benefit from any extended transition period, some of whom may not even be aware of their entanglement with the new regulation’s requirements, given their exemption from such obligations under the previous directive. EU MDR compliance does not solely apply to manufacturers of high-risk products as it is commonly assumed but to all manufacturers regardless of past classification, including Class I. With such misconceptions floating around, it is important to set things straight for all manufacturers. This article will aim to clarify matters, highlighting the principle changes and challenges that moving away from the previous MDD and embarking on the road toward EU MDR compliance entails, with a particular focus on the urgency for manufacturers to promptly join the queue for notified body assistance now, as they are likely to have to wait their turn for a full review of all technical documentation.
As a first point of action, manufacturers are advised to consult Annex VIII of the EU MDR, which will reveal any changes of classification, and in turn, any potential new conformity assessment routes they are to follow for their products. Indeed, the EU MDR contains not only four new classification rules but also some significant changes to pre-existing ones, some of which will altogether alter the category under which a product falls. Manufacturers must therefore swiftly become acquainted with these modifications, in order to first determine if their products have been up-classified to another sub-section of Class I, Class IIa, IIb, and Class III, or alternatively, if their product grouping remains untouched. If a manufacturer’s device remains a Class I device under the EU MDR, they may continue to self-certify as long as their technical documentation is up to date in time for the MDR deadline, for which they will need to self-declare the conformity of their devices with the requirements of the MDR and register relevant details on the EUDAMED database.
For Class I manufacturers that have found their products to be up-classified, however, this reshuffling may result in their devices being subject to regulation by a notified body for the first time. One particular illustration of this is Class I reusable surgical instruments, which as per Article 52 (7c) of the EU MDR, will now belong to a new category of their own, known as Class Ir. Products that fall under the new Class Ir group will require inspection of cleaning, repackaging, and reprocessing aspects from a notified body—something unprecedented given no such reviews were required for these products under the MDD. Other examples of this restructuring include spinal products (MDR Annex VII, rule 8), standalone software (MDR Annex VII, rule 11), and products without an intended medical purpose (Annex XVI). Similarly, given that grandfathering of products is not allowed under the EU MDR, medical devices that have already been circulating on the market for many years, but entered the market prior to an ongoing standard, directive, or regulation, will also need to receive new CE certification.
Having established the classification of their products under the new regulation, manufacturers are ready to begin taking the first steps toward achieving EU MDR compliance. This stage of the process will be most effective if manufacturers are able to establish a timeline for the implementation of these next stages of the operation. While some medical device manufacturers may have already initiated implementation efforts, others will require more time and guidance. Each business must therefore try to assess the timeframe and resources required to bring their compliance plans to fruition. The need for speed and efficiency is particularly crucial for Class I manufacturers; while other Classes of manufacturers who have been recertified under the MDD before 2020 can benefit from up to a four-year extension for the completion of compliance, Class I manufacturers have not been granted any additional time allowance and must achieve compliance by May 26, 2020.
Adding to the urgency of the situation is the untimely shortage of notified bodies operating throughout Europe, with multiple organizations withdrawing from medical device regulation, and the resulting issue of capacity across the medical device industry. With only three notified bodies having presently been designated under the EU MDR (the announcement of Germany-based Dekra Certification GmbH came in August), the regulatory expertise vital in assisting manufacturers will be hard to come by. It is estimated the number of available notified bodies will significantly rise before the end of 2019, suggesting the work would be divided up between approximately 16 to 20 notified bodies. While this is an improvement, the vast number of technical documents being submitted for review means these organizations will nonetheless undoubtedly find themselves overstretched. It is evident the number of cases waiting for a CE mark will largely outweigh the combined capacity of the available notified bodies and lead to delays. With a clear surplus of demand for regulatory certification services on the horizon, manufacturers must act quickly. If Class I manufacturers find their products have been up-classified, they should engage with a notified body right away before the latter find themselves at full capacity. Class I manufacturers too slow to join the regulatory waiting room may find their technical documentation has not been reviewed in time and may simply be left behind from the collective migration from MDD to EU MDR.
Needless to say, notified bodies are unlikely to have any time to offer any additional support, given the already strenuous task of delivering the bare minimum of essential reviews on time. Hard pressed to find the kind of supplementary support manufacturers may wish for, it is probable some manufacturers may wisely seek out regulatory expertise elsewhere. This kind of auxiliary assistance would be particularly beneficial for Class I manufacturers that have never been required to previously seek notified body review. By engaging with other expert entities, manufacturers will be able to gain immediate access to regulatory assistance while waiting in line for a notified body. This will not only diminish the huge strain on these organizations, but also allow manufacturers to ensure their technical documentation is all in order before submission, thus enabling an efficient, hassle-free compliance process for themselves. Moreover, in light of the uncertainty around Brexit, manufacturers are strongly encouraged to engage an Authorized Representative within the EU 27 in order to prepare as best as possible for the upcoming deadline and any eventual complications or delays.
At the forefront of a successful transition is the gathering of clinical data. Most Class I manufacturers are currently self-certified and rarely have the necessary quality management system or the clinical data to reach EU MDR compliance alone. Additional support would certainly be helpful in completing the new Quality Management System (QMS) requirements demanded of manufacturers under the EU MDR. Class I manufacturers will now require a formal QMS as per Article 10, paragraph 9, of the regulation, which is best served by implementing EN ISO 13485:2016. The QMS must include requirements for a formal Post-Market Surveillance report, which must be continuously and proactively updated with relevant clinical data, as cited in Article 85. All manufacturers will be subject to the post-market provisions of the MDR, including Post-Market Clinical Follow-Up, Post-Market Surveillance Update Reports, and vigilance reporting. These new regulatory requisites represent a considerable reform from the basic procedures required under the MDD.
By complying now, manufacturers can use available post-market clinical data or perform a post-market study to submit as clinical evidence within the technical documentation itself. On the other hand, manufacturers who fail to fulfill these specifications within the set deadlines will not only have to remove their non-compliant products from the EU market, but to make matters worse, will also be unable to collect precisely the clinical evidence needed to complete the technical documentation required for compliance. Such a scenario would be highly undesirable and problematic for any business. As such, Class I manufacturers should not underestimate the time, preparatory work, and resources required to meet total EU MDR compliance within the set times, and should engage with a notified body as soon as possible (if required), while also considering other available options of independent regulatory expertise. Complacency and insufficient resource and time allowances could prove highly damaging for ill-prepared manufacturers.
Class I manufacturers who wait too long to get in line to review their technical documentation are placing themselves in a precarious situation. As a matter of urgency, manufacturers should first read EU MDR Annex VIII in order to determine which classificatory amendments may impact the compliance requirements of their products. Next, manufacturers must immediately reach out to a notified body to achieve CE marking before waiting lines become too long and advisory capabilities are completely depleted. Finally, manufacturers are urged to seek out some supplementary expertise, to help ease the weight placed on the shoulders of notified bodies and to guarantee a smooth transition procedure for all. To successfully receive their required CE certifications by May 26, 2020, Class I manufacturers must prioritize EU MDR conformity and allow for enough time to gather the obligatory clinical data and have these reviewed by a notified body. With this deadline rapidly approaching, it is essential manufacturers recognize the overdemand for notified body input and quickly start piecing together their EU MDR technical documentation to submit for a speedy review.
Peter Rose is the managing director and practice leader for Maetrics’ operations in Europe. Having worked in the medical device industry for over 20 years, Rose has a wealth of experience and knowledge in quality systems and regulatory affairs. He is a lead auditor and a qualified microbiologist, and has been recognized for his extensive experience with sterilization.
Particularly vulnerable to being left behind are Class I manufacturers who cannot benefit from any extended transition period, some of whom may not even be aware of their entanglement with the new regulation’s requirements, given their exemption from such obligations under the previous directive. EU MDR compliance does not solely apply to manufacturers of high-risk products as it is commonly assumed but to all manufacturers regardless of past classification, including Class I. With such misconceptions floating around, it is important to set things straight for all manufacturers. This article will aim to clarify matters, highlighting the principle changes and challenges that moving away from the previous MDD and embarking on the road toward EU MDR compliance entails, with a particular focus on the urgency for manufacturers to promptly join the queue for notified body assistance now, as they are likely to have to wait their turn for a full review of all technical documentation.
As a first point of action, manufacturers are advised to consult Annex VIII of the EU MDR, which will reveal any changes of classification, and in turn, any potential new conformity assessment routes they are to follow for their products. Indeed, the EU MDR contains not only four new classification rules but also some significant changes to pre-existing ones, some of which will altogether alter the category under which a product falls. Manufacturers must therefore swiftly become acquainted with these modifications, in order to first determine if their products have been up-classified to another sub-section of Class I, Class IIa, IIb, and Class III, or alternatively, if their product grouping remains untouched. If a manufacturer’s device remains a Class I device under the EU MDR, they may continue to self-certify as long as their technical documentation is up to date in time for the MDR deadline, for which they will need to self-declare the conformity of their devices with the requirements of the MDR and register relevant details on the EUDAMED database.
For Class I manufacturers that have found their products to be up-classified, however, this reshuffling may result in their devices being subject to regulation by a notified body for the first time. One particular illustration of this is Class I reusable surgical instruments, which as per Article 52 (7c) of the EU MDR, will now belong to a new category of their own, known as Class Ir. Products that fall under the new Class Ir group will require inspection of cleaning, repackaging, and reprocessing aspects from a notified body—something unprecedented given no such reviews were required for these products under the MDD. Other examples of this restructuring include spinal products (MDR Annex VII, rule 8), standalone software (MDR Annex VII, rule 11), and products without an intended medical purpose (Annex XVI). Similarly, given that grandfathering of products is not allowed under the EU MDR, medical devices that have already been circulating on the market for many years, but entered the market prior to an ongoing standard, directive, or regulation, will also need to receive new CE certification.
Having established the classification of their products under the new regulation, manufacturers are ready to begin taking the first steps toward achieving EU MDR compliance. This stage of the process will be most effective if manufacturers are able to establish a timeline for the implementation of these next stages of the operation. While some medical device manufacturers may have already initiated implementation efforts, others will require more time and guidance. Each business must therefore try to assess the timeframe and resources required to bring their compliance plans to fruition. The need for speed and efficiency is particularly crucial for Class I manufacturers; while other Classes of manufacturers who have been recertified under the MDD before 2020 can benefit from up to a four-year extension for the completion of compliance, Class I manufacturers have not been granted any additional time allowance and must achieve compliance by May 26, 2020.
Adding to the urgency of the situation is the untimely shortage of notified bodies operating throughout Europe, with multiple organizations withdrawing from medical device regulation, and the resulting issue of capacity across the medical device industry. With only three notified bodies having presently been designated under the EU MDR (the announcement of Germany-based Dekra Certification GmbH came in August), the regulatory expertise vital in assisting manufacturers will be hard to come by. It is estimated the number of available notified bodies will significantly rise before the end of 2019, suggesting the work would be divided up between approximately 16 to 20 notified bodies. While this is an improvement, the vast number of technical documents being submitted for review means these organizations will nonetheless undoubtedly find themselves overstretched. It is evident the number of cases waiting for a CE mark will largely outweigh the combined capacity of the available notified bodies and lead to delays. With a clear surplus of demand for regulatory certification services on the horizon, manufacturers must act quickly. If Class I manufacturers find their products have been up-classified, they should engage with a notified body right away before the latter find themselves at full capacity. Class I manufacturers too slow to join the regulatory waiting room may find their technical documentation has not been reviewed in time and may simply be left behind from the collective migration from MDD to EU MDR.
Needless to say, notified bodies are unlikely to have any time to offer any additional support, given the already strenuous task of delivering the bare minimum of essential reviews on time. Hard pressed to find the kind of supplementary support manufacturers may wish for, it is probable some manufacturers may wisely seek out regulatory expertise elsewhere. This kind of auxiliary assistance would be particularly beneficial for Class I manufacturers that have never been required to previously seek notified body review. By engaging with other expert entities, manufacturers will be able to gain immediate access to regulatory assistance while waiting in line for a notified body. This will not only diminish the huge strain on these organizations, but also allow manufacturers to ensure their technical documentation is all in order before submission, thus enabling an efficient, hassle-free compliance process for themselves. Moreover, in light of the uncertainty around Brexit, manufacturers are strongly encouraged to engage an Authorized Representative within the EU 27 in order to prepare as best as possible for the upcoming deadline and any eventual complications or delays.
At the forefront of a successful transition is the gathering of clinical data. Most Class I manufacturers are currently self-certified and rarely have the necessary quality management system or the clinical data to reach EU MDR compliance alone. Additional support would certainly be helpful in completing the new Quality Management System (QMS) requirements demanded of manufacturers under the EU MDR. Class I manufacturers will now require a formal QMS as per Article 10, paragraph 9, of the regulation, which is best served by implementing EN ISO 13485:2016. The QMS must include requirements for a formal Post-Market Surveillance report, which must be continuously and proactively updated with relevant clinical data, as cited in Article 85. All manufacturers will be subject to the post-market provisions of the MDR, including Post-Market Clinical Follow-Up, Post-Market Surveillance Update Reports, and vigilance reporting. These new regulatory requisites represent a considerable reform from the basic procedures required under the MDD.
By complying now, manufacturers can use available post-market clinical data or perform a post-market study to submit as clinical evidence within the technical documentation itself. On the other hand, manufacturers who fail to fulfill these specifications within the set deadlines will not only have to remove their non-compliant products from the EU market, but to make matters worse, will also be unable to collect precisely the clinical evidence needed to complete the technical documentation required for compliance. Such a scenario would be highly undesirable and problematic for any business. As such, Class I manufacturers should not underestimate the time, preparatory work, and resources required to meet total EU MDR compliance within the set times, and should engage with a notified body as soon as possible (if required), while also considering other available options of independent regulatory expertise. Complacency and insufficient resource and time allowances could prove highly damaging for ill-prepared manufacturers.
Class I manufacturers who wait too long to get in line to review their technical documentation are placing themselves in a precarious situation. As a matter of urgency, manufacturers should first read EU MDR Annex VIII in order to determine which classificatory amendments may impact the compliance requirements of their products. Next, manufacturers must immediately reach out to a notified body to achieve CE marking before waiting lines become too long and advisory capabilities are completely depleted. Finally, manufacturers are urged to seek out some supplementary expertise, to help ease the weight placed on the shoulders of notified bodies and to guarantee a smooth transition procedure for all. To successfully receive their required CE certifications by May 26, 2020, Class I manufacturers must prioritize EU MDR conformity and allow for enough time to gather the obligatory clinical data and have these reviewed by a notified body. With this deadline rapidly approaching, it is essential manufacturers recognize the overdemand for notified body input and quickly start piecing together their EU MDR technical documentation to submit for a speedy review.
Peter Rose is the managing director and practice leader for Maetrics’ operations in Europe. Having worked in the medical device industry for over 20 years, Rose has a wealth of experience and knowledge in quality systems and regulatory affairs. He is a lead auditor and a qualified microbiologist, and has been recognized for his extensive experience with sterilization.
